Amneal Pharms NY

JUL 30, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for metformin hydrochloride labeling update; regulatory action without clinical trial data or efficacy claims.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing combination opioid–acetaminophen product; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a hydrocodone-acetaminophen combination tablet under REMS requirements; a regulatory action, not a clinical evidence base.